Uncontrolled evidence in rare cancers Paolo G. Casali - PowerPoint PPT Presentation

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Uncontrolled evidence in rare cancers Paolo G. Casali paolo.casali@istitutotumori.mi.it R Eur Eur J C J Can ance cer 201 r 2011;47 1;47:249 :2493 Clinical decision-making Methods to combine evidence New study designs

Uncontrolled evidence in rare cancers Paolo G. Casali paolo.casali@istitutotumori.mi.it
R
Eur Eur J C J Can ance cer 201 r 2011;47 1;47:249 :2493
Clinical decision-making  Methods to combine evidence  New study designs  Surrogate end points  Organization of studies 
Prospective clinical data bases
«Big clinical data»…
Phase I  MTD dose! activity! Phase II Phase III  OR  OS efficacy!  QoL standard
Lung cancer Boolell V et al. Cancers 2015;71815
Soft tissue sarcomas & GIST …….
STS: advanced disease ADM 75 mg/sqm R ADM 75 mg/sqm + IFX 7.5 g/sqm EORTC Soft Tissue & Bone Sarcoma Group
La Lanc ncet et On Onco col l 20 2014 14;15:41 ;15:415
J Clin Oncol 2015;Epub
Mol Cancer Therap 2009;8:449
Van an Der er Gra Graaf af WTA WTA et et al, al, La Lanc ncet et 20 2012 12;379 ;379:187 :1879
Van an Der er Gra Graaf af WTA WTA et et al, al, La Lanc ncet et 20 2012 12;379 ;379:187 :1879
Italiano A et al. Patterns of care and outcome of patients (pts) with metastatic soft-tissue sarcoma (STS) according to histological subtype and treatment setting: The METASTAR study. ASCO Ann. Meet. 2016, #11014
Leiomyosarcoma ADM GEM TRB DTIC PAZO
t T response progression
Tumor response as a surrogate
Quality of life -% ?
Quality of life -% ?
Survival… -% ?
BMJ 2003;327:1459
N N Eng Engl l J M J Med ed 198 1987;31 7;316:25 6:250
GIST: tumor response
GIST: tumor response Choi’s 10% 15%
Choi’s RECIST
-13 HU 9 HU 15 HU 36 HU 83 HU - 18 HU -34 HU -9 HU 5 HU 9 HU 52 HU 57 HU - 2 HU 61 HU 3 HU 13 HU 5 HU 20 HU 39 HU 3 HU 10 HU 57 HU
Immune therapies: tumor response Postow MA et al. J Clin Oncol 2015;33:1974
Karnofsky DA, 1961;6:709
Reliability (reproducibility) = !
J Na J Natl tl Can ance cer r In Inst 2 st 200 000;92 0;92:205 :205
J Na J Natl tl Can ance cer r In Inst 2 st 200 000;92 0;92:205 :205
1. Personalized tool -% ?
2. Volume
3. Non-dimensional changes
4. Temporal dimension t
5. Continuous variable
6. Growth rate t
t
Boo ooth th CM et et al. al. Eur J C Eur J Can ance cer r 20 2008 08;44:25 ;44:25
Con ontr troll oll Cli lin n Trials rials 20 2000 00;21:34 ;21:343
Reliability (reproducibility) = !
paolo.casali@istitutotumori.mi.it @casali_pg

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